Monday, March 18, 2013

Quality and Accreditation: Partnership or What?

Quality and Accreditation: Partnership or What?
Module 3 of our certificate course in Laboratory Quality Management is always of great interest to me.  It is here that we introduce the concept of Quality Partners.  This is a topic that comes up frequently in this web-journal. [ see: ]

With wanting to be unduly repetitive, there are organizations whose raison d’etre is in large part to support medical laboratories around the world,… to make them better places.  The partners include Standards Development Organizations (SDOs), Accreditation Bodies (ABs), Proficiency Testing Schemes (PTs), Education Providing Institutions (EPs), Professional Organizations (POs) and Industry Suppliers (IND).  Each of these groups is instrumental in supporting a laboratory’s efforts to learn, implement, and maintain a Quality structure. 

Each year a question arises, which tests (at least in my opinion) the understanding that laboratorians have about who does what and who is responsible for what and who has authority.

There appears to be confusion between Quality and Accreditation; are they two sides of the same coin, or are they Partners in purpose. 

Accreditation Bodies are very important to the medical laboratory.  They gather documents written under the authority of SDOs, interpret them, devise strategies on how to measure them, and then action the strategies.  They provide an external eye that informs laboratorians, and others, in their respected opinion, that the SDO developed document is being adhered to, or is not.  They provide a method that measures Quality.
And where Quality is being missed, by their measurement, they can highlight where improvements can or must be made, in order to allow for the AB to affirm compliance and competence. 

It is a process that provides an invaluable assist.

But, can Quality and competence exist outside of Accreditation?  This is very different from the philosophical conundrum of “if a tree falls in the forest, and nobody is around, does it make a sound?”.  With the tree, if there are no ear-drums around, then all the vibration from the falling tree is for naught.  No ear-drums, no sound.  But in the laboratory, even without an external visit, or a certificate, a laboratory can still faithfully adhere to all the requirements of Quality.

Laboratorians can and do acquire documents themselves, interpret them themselves, plan implementation themselves and monitor outcomes themselves.  Faithful adherence is a matter of choice and will.  This is the process in jurisdictions that do not mandate accreditation but endorse the values of Quality.

Is it a hard process? Absolutely.  Does it fail frequently? Absolutely absolutely.  But can it work?  Absolutely absolutely absolutely, sort of.  In my experience, there are all sorts of good examples to support the notion.  I have visited laboratories that where management decided that adopting ISO15189 was a good idea.  They came upon the decision on their own.  Through the use of consultants they went through the process of implementation, and worked hard to maintain what they had achieved.  Eventually they found that there was value, in going through a voluntary affirmation by hiring an AB from another country to look over what they had done, and indeed received their certificate of accreditation. 
There is much to be gained through the external process of assessment, and in terms of building a Culture of Quality, the process of external assessment can serve as a positive binding force.  But the power to decide and create and maintain is one that can, and indeed must come from within.

Let me argue that in the absence of separate, independent SDOs, the risk of biased documents becomes very high and the value of Quality becomes questionable.  In the absence of IND committed to effective efficient consistent equipment and supplies and an ongoing program of maintained assured product quality, the laboratory has no chance at all.  In the absence of EDs and POs and PTs that promote Quality through education and challenge and continuing education, the message is lost.  All these Partners assist the laboratory, some I would argue more powerfully and more permanently than others. 
So, if there is a truism here it is that the spirit and commitment to Quality can and must come from within.  Quality Partners can and do provide the essential and powerful supports and affirmation and validation. 

Without the internal spirit and commitment, Quality will always fail.


  1. Thanks for the informative post. I know how much red tape you need to go through in order to get accreditation, we were just awarded with our A2LA and ISO 17020 accreditations. Are those two applicable to medical labs?

    1. First off, congratulations on your accreditation. I know A2LA well. I am sure your assessment was both tough and fare.
      Breaking into the accreditation of medical laboratories is a real challenge at least in much of the resourced world because in those countries, provinces and states accreditation is regulated or locked-up by established organizations.
      That being said there are many resource limited countries that need the help.


  2. This is an interesting article. It is very hard to buy medical laboratory supplies in stores. I need to get more familiar with certain supplies because I am now working in a hospital.


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